Monthly CERA Treatment Maintains Stable Hemoglobin Levels in Routine Clinical Practice of Peritoneal Dialysis Patients

Abstract

Data on routine use of continuous erythropoietin receptor activator (CERA) in peritoneal dialysis patients are scarce. This study aimed to assess the efficacy of CERA administered once monthly in maintaining stable Hb levels in patients on peritoneal dialysis under routine medical practice. This was a 12-month, observational, prospective and multicenter study. A total of 83 patients with anemia secondary to chronic kidney disease (CKD) on peritoneal dialysis for more than 3 months, on once-monthly subcutaneous CERA treatment, were followed up over a period of 1 year. Efficacy evaluation included Hb levels, mean time in which the Hb level was maintained within target range, CERA doses and number of dose changes. Median Hb level (interquartile range [IQR]) remained stable during the evaluation period [11.8 AE 1.4 g/dL at baseline, 11.8 AE 1.4 g/dL at month 6 and 11.8 AE 1.5 g/dL at month 12 ( p > 0.05)]. The median (IQR) time of Hb level maintained within target range (11-13 mg/dL) was 6 (4-10) months. Ferritin, transferrin saturation index, and Fe were also stable and well maintained during the 12 months ( p > 0.05). CERA mean dose (SD) was [115.4 (56.2) μg baseline; 117.2 (58.5) μg 6 months; 126.0 (65.9) μg 12 months ( p ¼ 0.127)]. The mean number of CERA dose changes per patient during the study was 1.6 (SD 1.3). Serious adverse events were not related to CERA treatment. The results suggest that oncemonthly CERA successfully corrects anemia and maintains stable Hb levels within the recommended target range on peritoneal dialysis under routine medical practice.

Comparison of 2‐Week Versus 4‐Week Dosing Intervals of Epoetin Beta Pegol on Erythropoiesis and Iron Metabolism in Hemodialysis Patients

“…Hemoglobin levels in dialysis patients could be stabilized by either a once monthly or biweekly administration of CERA . However, precise differences regarding iron metabolism between the two dosing intervals have not yet been clarified.…”

2015 Japanese Society for Dialysis Therapy: Guidelines for Renal Anemia in Chronic Kidney Disease

“…There has been only one article published in Japanese reporting that CERA was safely used when the target Hb levels were set at 10-12 g/dL [62]. In other countries, there has been only one study of switching to CERA in PD patients [63]. Anemia in patients was well controlled after switching agents in all of these reports, indicating that there were no safety issues when the upper limit of the Hb level range was set at ≥12 and <13 g/dL (Table 5).…”

Beneficial dose conversion after switching from higher doses of shorter-acting erythropoiesis-stimulating agents to C.E.R.A in CKD patients in clinical practice: MINERVA Study

“…However, in this study, patients starting monthly C.E.R.A doses were 125 lg and 200 lg, and the effect of subsequent C.E.R.A dosing decisions was evaluated during a 7-month period. On the other hand, the efficacy in maintaining haemoglobin levels after switching to C.E.R.A doses lower than those recommended by the SPC has also been confirmed in peritoneal dialysis patients [39].…”